Telephone Support vs. Self-guidance in an Internet-based Self-administered Psychological Program to Address Depression

NCT ID: NCT06230237

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-12-30

Brief Summary

Depression is a first level problem that poses a challenge for Primary Care (PC). The overload of care in this area requires lower-cost and more accessible alternatives. Internet-based self-applied cognitive behavioral treatments (CBCT) have demonstrated their efficacy and added advantages. The "Smiling is fun" program has been validated in Spanish PC and has demonstrated its usefulness and cost-effectiveness. Previous studies have shown that professional support or guidance increases the results of the TCCI.

The aim of the present study is to contrast, by means of a randomized controlled trial, aims to examine the effectiveness, adherence rates, and implementation process of Smiling is Fun to address depression in a PC setting considering the influence of telephone support vs no support.

Ultimately, the results of the study could help in the uptake of sustainable resources so that the population could gain better access to psychological interventions in mental health services.

Detailed Description

Background: Depression is already the leading psychological disability around the world, impairing daily life, well-being, and social functioning and leading to personal and social costs. Despite the effectiveness of Evidence-Based Psychological Practices (EBPP), a significant percentage of depressive individuals remain untreated, especially in Primary Care (PC) settings in Spain. There are numerous barriers that limit access to EBPPs, including high costs, professional training, and adherence problems. Information and Communication Technologies (ICTs) offer a cost-effective way to disseminate and scale EBPPs to address these barriers. The iCBT program Smiling is Fun has been demonstrated to be a cost-effective treatment for depression in various Randomized Control Trials. However, adherence and implementation problems in real-world settings need to be addressed. Implementation research can help evaluate these challenges by identifying facilitators and barriers to the implementation process in PC. In this regard, guided support has been pointed out as a possible key factor in addressing the population's mental health needs and promoting treatment adherence. Objective: The current study aims to examine the effectiveness, adherence rates, and implementation process of Smiling is Fun to address depression in a PC setting considering the influence of telephone support vs no support. Methods: The proposed research is a Hybrid Effectiveness-Implementation Type I study, with a two-armed randomized controlled design, which will test a clinical intervention for major depressive disorder while gathering information on its implementation in a real-world setting. The study will include adult patients with mild to moderate symptoms of depression. Participants will be randomly assigned to one of two groups: self-applied psychotherapy or self-applied psychotherapy with psychotherapeutic telephone support. The trial will recruit 100 patient participants, with a loss-to-follow-up rate of 30%. Discussion: A study protocol for a hybrid effectiveness-implementation study is presented with the aim to assess the implementation of Smiling is Fun for the treatment of depression in PC. The study evaluates the influence of telephone support during a self-administered intervention compared to unguided self-administration. The main goal is to address the barriers and facilitators of the implementation process and to promote treatment adherence. Ultimately, the results of the study could help in the uptake of sustainable resources so that the population could gain better access to psychological interventions in mental health services.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Professional support

Participants randomly assigned to this groups will receive the self-administered psychotherapy via the Internet a with telephone psychotherapeutic support.

Group Type: ACTIVE_COMPARATOR

Smiling is fun + professional support

Intervention Type: BEHAVIORAL

Participants will receive an intervention called Smiling is Fun; a cognitve-conductual online program with the most effective psychological procedures for depression and other techniques to promote coping ability, emotional regulation and resilience along 8 modules.

While they do the online program, they will receive periodically professional support. The professional support will be contacts of 20 minutes long, will take place every two weeks and will last 3 months.

Non professional support

Participants randomly assigned to this group will receive the self-administered psychotherapy via the Internet without telephone psychotherapeutic support.

Group Type: ACTIVE_COMPARATOR

Smiling is fun

Intervention Type: BEHAVIORAL

Participants will receive an intervention called Smiling is Fun; a cognitve-conductual online program with the most effective psychological procedures for depression and other techniques to promote coping ability, emotional regulation and resilience along 8 modules.

Interventions

Smiling is fun + professional support

Participants will receive an intervention called Smiling is Fun; a cognitve-conductual online program with the most effective psychological procedures for depression and other techniques to promote coping ability, emotional regulation and resilience along 8 modules.

While they do the online program, they will receive periodically professional support. The professional support will be contacts of 20 minutes long, will take place every two weeks and will last 3 months.

Intervention Type: BEHAVIORAL

Smiling is fun

Participants will receive an intervention called Smiling is Fun; a cognitve-conductual online program with the most effective psychological procedures for depression and other techniques to promote coping ability, emotional regulation and resilience along 8 modules.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18 to 65 years.
• Ability to understand and read Spanish.
• Meet diagnostic criteria for major depressive disorder (DSM-5).
• Mild or moderate symptoms of the Spanish version of the Beck Depression Inventory-II (BDI-II) (14-19: mild depression; 20-28: moderate depression).
• Episode duration of more than two weeks.
• Have internet access at home and an email account.
• The diagnosis of major depressive disorder will be confirmed by the standardized MINI International Neuropsychiatric Interview.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Francesc de Borja

UNKNOWN

Sponsor Role: collaborator

Universitat Jaume I

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Azucena García Palacios

Role: STUDY_CHAIR

Universidad Jaume I

Pedro Vera Albero

Role: STUDY_DIRECTOR

F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja

Raquel Escriva Sanchis

Role: STUDY_CHAIR

F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja

Clara Bretó García

Role: STUDY_CHAIR

F.E.D. Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja

Locations

Psicología Clínica Unitat de Salut Mental Hospital Francesc de Borja

Tavernes de la Valldigna, Valencia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Rosa Lorente Català

Role: CONTACT

rlorente@uji.es

691527941 ext. 0034

Facility Contacts

Rosa Lorente Català

Role: primary

References

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Reference Type: BACKGROUND

PMID: 31133899 (View on PubMed)

Romero-Sanchiz P, Nogueira-Arjona R, Garcia-Ruiz A, Luciano JV, Garcia Campayo J, Gili M, Botella C, Banos R, Castro A, Lopez-Del-Hoyo Y, Perez Ara MA, Modrego-Alarcon M, Mayoral Cleries F. Economic evaluation of a guided and unguided internet-based CBT intervention for major depression: Results from a multi-center, three-armed randomized controlled trial conducted in primary care. PLoS One. 2017 Feb 27;12(2):e0172741. doi: 10.1371/journal.pone.0172741. eCollection 2017.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 28408833 (View on PubMed)

Lorente-Catala R, Font-Furnieles P, Escriva-Sanchis R, Berto-Garcia C, Vera-Albero P, Garcia-Palacios A. Telephone support vs. self-guidance in an Internet-based self-administered psychological program for the treatment of depression: Protocol for a hybrid type 1 effectiveness-implementation randomized controlled trial. Internet Interv. 2024 Apr 20;36:100742. doi: 10.1016/j.invent.2024.100742. eCollection 2024 Jun.

Reference Type: DERIVED

PMID: 38737981 (View on PubMed)

Other Identifiers

FISABIO

Identifier Type: -

Identifier Source: org_study_id